Gabapentin is an anti-epileptic agent that has shown preliminary evidence of efficacy for
improving symptoms of cocaine and alcohol withdrawal in pilot studies. Since the neurobiology
of alcohol, cocaine and nicotine withdrawal is similar, the preliminary evidence of efficacy
of gabapentin for symptoms of alcohol and cocaine withdrawal suggests, that gabapentin might
likely help nicotine withdrawal symptoms and thus tobacco abstinence. The effect of
gabapentin on two of the neurotransmitters, gamma-aminobutyric acid (GABA) and glutamate
further suggest a potential therapeutic mechanism for gabapentin in tobacco abstinence.
However, the exact mechanism of action of gabapentin is currently not known. We have recently
completed an open label pilot trial of gabapentin for tobacco abstinence involving 50
smokers. The findings from that study provide promising preliminary results and suggest that
further testing of gabapentin for helping cigarette smokers quit tobacco use is worth
pursuing. Overall, gabapentin is well tolerated and has low abuse potential.
Our goal is to evaluate novel, safe, acceptable, and effective therapies that may help
increase tobacco abstinence rates. Currently, no randomized trials testing the efficacy of
gabapentin for smoking abstinence have been published. While our previous study provides
promising evidence regarding the potential efficacy of gabapentin for smoking abstinence, an
additional dose ranging study is needed prior to pursuing a large randomized trial. The
primary aim of the dose ranging study will be to obtain additional evidence of efficacy, and
information on the optimal dose of gabapentin to employ in the larger randomized controlled
trial.